Epoetin Alfa in Advanced Non-Small Cell Lung Cancer (EPO-CAN-20)

NCT ID: NCT00310232

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2004-04-30

Brief Summary

The general objective of this study is to improve the Quality of Life (QoL) of selected patients with advanced carcinoma of the lung. The specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related QoL and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.

Conditions

Non-Small-Cell Lung Carcinoma; Lung Cancer; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Epoetin Alfa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage III or IV, or recurrent disease; and

2. Hemoglobin level at or below 120 g/L; and

3. At least 18 years of age;

Exclusion Criteria

1. Systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months;

2. Patients previously treated with high dose thoracic radiation (>10 fractions), or surgery, without objective evidence of disease recurrence;

3. Planned high dose thoracic radiation therapy (>10 fractions);

4. A clinically active malignancy, other than the underlying lung cancer which is expected to influence QoL;

5. Expected survival of three months or less;

6. ECOG Performance status of 3 or 4 (see Appendix D);

7. Multiple CNS metastasis or a single CNS lesion that does not demonstrate radiographic stability (Screening CT of head required only if symptomatic, no radiographic follow-up of single resected lesions required);

8. Blood transfusions within the last 14 days;

9. Previous use of erythropoietin;

10. Anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding);

11. Evidence of untreated folate or vitamin B12 deficiency;

12. History of uncontrolled hypertension or diastolic blood pressure greater than 100 mm Hg;

13. History of seizure disorder;

14. Known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug;

15. Pregnancy, lactation or parturition within the previous 30 days;

16. Unwillingness or inability to complete the required QoL questionnaires;

17. Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires;

18. Geographically inaccessible for treatment or follow-up evaluations;

19. Currently enrolled in an ongoing therapeutic study;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Principal Investigators

Jim Wright, MD

Role: STUDY_CHAIR

Hamilton Regional Cancer Centre

Mark Levine, MD

Role: STUDY_DIRECTOR

Ontarion Clinical Oncology Group

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

St. John Regional Hospital

Saint John, New Brunswick, Canada

Newfoundland Cancer Treatment & Research Foundation

St. John's, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Hamilton Regional Cancer Centre (Juravinski)

Hamilton, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

Hotel Dieu Hospital

Saint Catherines, Ontario, Canada

Toronto East General Hospital

Toronto, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

McGill University Clinical Trials Operations

Montreal, Quebec, Canada

Countries

Canada

References

Wright JR, Ung YC, Julian JA, Pritchard KI, Whelan TJ, Smith C, Szechtman B, Roa W, Mulroy L, Rudinskas L, Gagnon B, Okawara GS, Levine MN. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia. J Clin Oncol. 2007 Mar 20;25(9):1027-32. doi: 10.1200/JCO.2006.07.1514. Epub 2007 Feb 20.

Reference Type: RESULT

PMID: 17312332 (View on PubMed)

Other Identifiers

HC File 9427-J0921-22C

Identifier Type: -

Identifier Source: secondary_id

CTA-Control-076080

Identifier Type: -

Identifier Source: org_study_id